Job Description
Exyte is a global leader in design, engineering and delivery of facilities for high-tech industries - serving people and planet by energy saving & more sustainable engineering.
As (Junior) Project Engineer (m/f/d) Pharma / Food with focus on Qualification / Validation, you work in the Bio Life Sciences sector at Exyte Central Europe and report to the Group Lead Qualification & Validation. You are going to be assigned to our regional office in Nuremberg and with our clients on-site to qualify the respective equipment and facilities. In a team of highly qualified and experienced qualification & validation engineers you will be covering exiting pharma projects. Mobile working is also a possibility, depending on the project.
- Responsible handling of project-specific qualification and validation activities according to current GMP regulations for HVAC-, Cleanroom- & Clean Media-Systems
- Preparation and review of qualification & validation documents (specifications, risk analysis, plans and reports)
- Preparation of test protocols for different qualification stages (DQ, IQ, OQ, PQ) and being responsible for their execution
- Responsible for supplier coordination and review of supplier documentation (FAT/ SAT, technical documents)
- Responsible for the communication between qualification, customer/user, technical engineers, automation, QA, and suppliers as well as reporting to the CQV manager /project management
- During the implementation phase, you are on-site to coordinate and conduct the qualification independently. You are able to work under time pressure and to successfully drive the project forward
- Completed studies in the field of biotechnology, pharmaceutical or process engineering, medical devices or a related field of study
- Relevant technical knowledge of current regulations in qualification and validation (GMP, ISO, 21 CFR, Annex 15, data integrity, ISO14644)
- You have gained a first insight into qualification/validation during your first job or during an internship (ideally in the life sciences industry)
- Fluent written and oral communication skills in English. Good German skills are required
- Proactive and independent working style as well as a high level of quality awareness, efficiency and accuracy